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- Convenience Kit Correction: Argon Medical Issues Correction for Convenience Kits Containing Spectra Medical Device Lidocaine AmpulesArgon Medical is correcting affected convenience kits by removing included Spectra Medical Devices Lidocaine Ampules.fda medwatch · 12h ago↗ source
- Industry urges FDA to clarify and broaden QSP guidance for first-in-human dose selectionIndustry stakeholders have asked the U.S. Food and Drug Administration for more detailed guidance on using quantitative systems pharmacology (QSP) to select first-in-human doses in phase-1 studies.…